Peripheral Arterial DiseaseNCT03564080
Assessing the Feasibility of Including Patients With Peripheral Artery Disease in to an Established Cardiac Rehabilitation Service.
A study testing Combined - PAD and CAD in people with Peripheral Arterial Disease and Cardiovascular Diseases, run by University of Salford at 1 site in United Kingdom.
Trial summary
This study will investigate if patients with peripheral artery disease (PAD) can be successfully incorporated into an already existing Cardiac Rehabilitation programme. One group of PAD patients will exercise as a group, and the other group will exercise alongside patients with coronary artery disease (CAD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease, Cardiovascular Diseases, Intermittent Claudication
- What is being tested?
- Combined - PAD and CAD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2018to 11 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- General criteria As part of this study participants will be required to wear an accelerometer on the first week and last week of the 12 week study. The accelerometer will be kept in place by a medical dressing (e.g. Tegederm). People with an existing skin condition such as psoriasis or eczema that would be affected by the application of a medical dressing will be excluded from the study.
- All participants must be able to start the incremental shuttle walk test (walking speed of 1.8kph, 1.1 mph).
- All participants must be able to engage in the exercises prescribed in the programme
- All patients recruited will have had a recent diagnosis (0 - 12 months) of PAD made by either a vascular surgeon, vascular specialist nurse or specialist podiatrist.
- All patients recruited to the CR group will have had a recent diagnosis (0-12 months) of CAD (angina, myocardial infarction (MI), or coronary artery bypass graft (CABG) or valve surgery).
Who cannot join
- Any patient who has had previous intervention for PAD e.g. balloon angioplasty, stent, bypass or medication, or who have previously completed an SEP will be excluded from the study. This is due to the possibility of previous interventions having an impact on patient perceptions.
- Participants who are on medication for PAD (e.g. naftidrofuryl oxalate) will also be excluded from the study as this can increase symptom management and improve functional capacity.
- Any PAD patient who also has a diagnosis of other cardiovascular conditions such as CAD or stroke, or chronic heart failure will be excluded from this study, as the investigation is looking at the specific improvements in PAD, not CAD gains.
- Any patient who has had previous diagnosis of PAD will be excluded from the study, as this may mask any gains in improvement due to CAD-specific rehabilitation in the CAD group (Tam et al., 2016).
- Any participant who has unstable CAD (e.g. unstable angina) will be excluded from the study as this is a contraindication partaking in structured exercise programme (BACPR, 2012).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal NHS Foundation Trust
Salford, Manchester, M6 8HD
About this study
Official title: An Investigation Into the Feasibility of Incorporating an Exercise Rehabilitation Programme for People With Peripheral Artery Disease Into an Already Established Cardiac Rehabilitation Service.
This study will investigate if patients with peripheral artery disease (PAD) can be successfully incorporated into an already existing Cardiac Rehabilitation programme. One group of PAD patients will exercise as a group, and the other group will exercise alongside patients with coronary artery disease (CAD).
Read the detailed description
Peripheral artery disease (PAD) is a progressive disease that occurs as the result of atherosclerotic plaque formation in the major arteries of the leg (Mays, Casserly and Regesteiner, 2013). The main presenting symptom of PAD is intermittent claudication (IC) - exertional pain or discomfort in the calf, thigh or buttock that is relieved with rest. The presence of PAD is a very powerful marker of cardiovascular risk and preventable cardiovascular deaths. Following the initial diagnosis of PAD, for those patients without coronary artery disease the risk of systemic morbidity or mortality in the next 5 years is 50% (AACVPR, 2013). In 2012, the National Institute for Health and Care Excellence (NICE) issued guidelines stating that supervised exercise programmes (SEPs) should be offered as first-line treatment for people diagnosed PAD. However, there is a national shortage of dedicated SEPs for PAD patients that UK vascular specialists can refer patients to. There has been suggestion that an already established network of Cardiac Rehabilitation (CR) departments within the United Kingdom (UK) could cater for this group of patients, as they already have facilities and staff in place. To date, there has been no investigation into whether this would be successful. This research project would investigate if CR programmes could get the same outcomes for PAD patients as a stand-alone PAD rehabilitation programme. The study would investigate the possible positive and negative impact on both the PAD and CR patient groups in attending a combined rehabilitation programme of exercise and education. It will also look at the perceptions of the participants regarding the treatment programme itself.
- Conditions
- Peripheral Arterial Disease, Cardiovascular Diseases, Intermittent Claudication, Coronary Artery Disease
- Being tested
- Combined - PAD and CAD
- Keywords
- exercise rehabilitation, supervised exercise programmes
- Medical subject headings
- Peripheral Arterial Disease, Cardiovascular Diseases, Intermittent Claudication, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined - PAD and CADOther
12-week supervised exercise programme in a hospital setting
| Study group | Role | What they receive |
|---|---|---|
| Control - PAD | No intervention | This group of patients will complete the 'standard care' of supervised exercise as recommended by NICE. |
| Combined - PAD and CAD | Experimental | This group of PAD patients will exercise alongside CAD patients in an established supervised exercise programme (Cardiac Rehabilitation). Receives: Other: Combined - PAD and CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance
Initial and maximal pain free walking distances are measured using a Incremental Shuttle Walk Test. The symptoms of claudication pain are identified using the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) 0-4 Claudication scale. 0 is no claudication; 1 is initial pain; 2 is moderate pain; 3 is severe; 4 is maximal pain.
Measured: 12 weeks
Secondary outcomes (4)
Walking Impairment Questionnaire
Patient's perceived walking distance and speed related to their claudication pain. Participants rate the distance and speed they are able to walk at. The distances are separated in to the amounts of blocks they can walk (with and without impairment). They then rate the speed they can walk 100 yards. The lower the score the worse the perceived limitation of their claudication symptoms.
Measured: 12 weeks
King's College Vascular Quality of Life Questionnaire (VascQual)
Disease-specific quality of life questionnaire. The questionnaire is 25-item questionnaire subdivided into five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items). The higher the score the lower the health-related quality of life.
Measured: 12 weeks
Free-living physical activity levels
Accelerometer data recording activity levels outside of rehabilitation programme
Measured: 12 weeks
Hospital Anxiety and Depression Scale
The is a generic quality of life questions that assesses levels of anxiety and depression. There are 14 questions questions in total, 7 questions on anxiety and 7 on depression. Each question has an answer rating from 0-3, with 0 being no evidence of anxiety/depression, and 3 being maximum score. The total score for anxiety and depression are added (but anxiety and depression scores are not combined) to see the total reading for anxiety and depression. If 11 or above is scored in either anxiety or depression, then referral to appropriate health care professional is discussed with participant.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start18 Jul 2018
- Primary completion28 Oct 2019
- Study completion11 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomised control trial assessing feasibilty of new treatment method - combined supervised exercise programme
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Responsible party
- Principal investigator, Edward Caldow, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564080
- Sponsor's protocol ID
- HSR1617-184
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2018
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Feasibility of Incorporating an Exercise Rehabilitation Programme for People With Peripheral Artery Disease Into an Already Established Cardiac Rehabilitation Service.
- ClinicalTrials.gov ID
- NCT03564080
- Acronym / sponsor ID
- HSR1617-184
- Conditions
- Peripheral Arterial Disease, Cardiovascular Diseases, Intermittent Claudication, Coronary Artery Disease
- Keywords
- exercise rehabilitation, supervised exercise programmes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 11 Sep 2022 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate if patients with peripheral artery disease (PAD) can be successfully incorporated into an already existing Cardiac Rehabilitation programme. One group of PAD patients will exercise as a group, and the other group will exercise alongside patients with coronary artery disease (CAD).
Detailed description
Peripheral artery disease (PAD) is a progressive disease that occurs as the result of atherosclerotic plaque formation in the major arteries of the leg (Mays, Casserly and Regesteiner, 2013). The main presenting symptom of PAD is intermittent claudication (IC) - exertional pain or discomfort in the calf, thigh or buttock that is relieved with rest. The presence of PAD is a very powerful marker of cardiovascular risk and preventable cardiovascular deaths. Following the initial diagnosis of PAD, for those patients without coronary artery disease the risk of systemic morbidity or mortality in the next 5 years is 50% (AACVPR, 2013). In 2012, the National Institute for Health and Care Excellence (NICE) issued guidelines stating that supervised exercise programmes (SEPs) should be offered as first-line treatment for people diagnosed PAD. However, there is a national shortage of dedicated SEPs for PAD patients that UK vascular specialists can refer patients to. There has been suggestion that an already established network of Cardiac Rehabilitation (CR) departments within the United Kingdom (UK) could cater for this group of patients, as they already have facilities and staff in place. To date, there has been no investigation into whether this would be successful. This research project would investigate if CR programmes could get the same outcomes for PAD patients as a stand-alone PAD rehabilitation programme. The study would investigate the possible positive and negative impact on both the PAD and CR patient groups in attending a combined rehabilitation programme of exercise and education. It will also look at the perceptions of the participants regarding the treatment programme itself.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomised control trial assessing feasibilty of new treatment method - combined supervised exercise programme
| Arm | Type | Receives |
|---|---|---|
| Control - PAD | No intervention | –This group of patients will complete the 'standard care' of supervised exercise as recommended by NICE. |
| Combined - PAD and CAD | Experimental | Other: Combined - PAD and CADThis group of PAD patients will exercise alongside CAD patients in an established supervised exercise programme (Cardiac Rehabilitation). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- General criteria As part of this study participants will be required to wear an accelerometer on the first week and last week of the 12 week study. The accelerometer will be kept in place by a medical dressing (e.g. Tegederm). People with an existing skin condition such as psoriasis or eczema that would be affected by the application of a medical dressing will be excluded from the study.
- All participants must be able to start the incremental shuttle walk test (walking speed of 1.8kph, 1.1 mph).
- All participants must be able to engage in the exercises prescribed in the programme
- All patients recruited will have had a recent diagnosis (0 - 12 months) of PAD made by either a vascular surgeon, vascular specialist nurse or specialist podiatrist.
- All patients recruited to the CR group will have had a recent diagnosis (0-12 months) of CAD (angina, myocardial infarction (MI), or coronary artery bypass graft (CABG) or valve surgery).
Key exclusion criteria (5 listed)
- Any patient who has had previous intervention for PAD e.g. balloon angioplasty, stent, bypass or medication, or who have previously completed an SEP will be excluded from the study. This is due to the possibility of previous interventions having an impact on patient perceptions.
- Participants who are on medication for PAD (e.g. naftidrofuryl oxalate) will also be excluded from the study as this can increase symptom management and improve functional capacity.
- Any PAD patient who also has a diagnosis of other cardiovascular conditions such as CAD or stroke, or chronic heart failure will be excluded from this study, as the investigation is looking at the specific improvements in PAD, not CAD gains.
- Any patient who has had previous diagnosis of PAD will be excluded from the study, as this may mask any gains in improvement due to CAD-specific rehabilitation in the CAD group (Tam et al., 2016).
- Any participant who has unstable CAD (e.g. unstable angina) will be excluded from the study as this is a contraindication partaking in structured exercise programme (BACPR, 2012).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined - PAD and CAD12-week supervised exercise programme in a hospital setting | Other | Combined - PAD and CAD |
Primary outcome
Walking distance
Time frame: 12 weeks
Initial and maximal pain free walking distances are measured using a Incremental Shuttle Walk Test. The symptoms of claudication pain are identified using the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) 0-4 Claudication scale. 0 is no claudication; 1 is initial pain; 2 is moderate pain; 3 is severe; 4 is maximal pain.
4 secondary outcomes
Walking Impairment Questionnaire
Time frame: 12 weeks
King's College Vascular Quality of Life Questionnaire (VascQual)
Time frame: 12 weeks
Free-living physical activity levels
Time frame: 12 weeks
Hospital Anxiety and Depression Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined - PAD and CAD in people with Peripheral Arterial Disease and Cardiovascular Diseases, run by University of Salford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.